Planes, Veins, and Automobiles. The impact of ISO 9001:2015 on AS9100, ISO 13485 and TS 16949
The standards AS9100 (Aerospace), ISO 13485 (Medical devices) and TS 16949 (Automotive)
are all directly based on ISO 9001:2008 and explicitly refer to its clauses. The
publication of ISO 9001:2015 has introduced questions and created dialogue about the
impact this newly revised standard will have on the other standards.
Will the AS 9100, ISO 13485 and TS16949 Standards align with ISO 9001:2015, and follow
the new High Level Structure (Annex SL)? Or will they take a different route and develop
their own framework, parting company with ISO 9001 and Annex SL?
Respective Industry and regulatory committees are currently reviewing AS9100, ISO 13485
and TS 16949 to make decisions about the transition of these standards: Certified
companies must plan effectively to ensure their management systems continue to meet
these Standards' requirements until the situation is clarified.
What this webinar will cover:
We will outline the current situation with AS9100, ISO 13485 and TS 16949, and clarify
what is happening and what is not happening.
We will provide you with the information you need to know regarding your specific
standard and what you need to do to ensure conformance going forward.
We will provide timelines for certified clients so you are well prepared for your
Our panel of specialists will be able to answer any questions or concerns you have about
ISO 9001:2015 and its impact on your management system.
John DiMaria is the Sr. Product Manager, Systems Certification, for BSI
Americas and Co-Chair of the CSA, OCF, and CTP Working Groups.
Ed Gagnon is BSI's Technical Manager for Aviation, Space, and
Defense. Ed brings years of experience as an executive in charge of maintaining quality
and airworthiness in the ASD sector.
Stewart Brain is the QMS Certification Lead at BSI Medical Devices and
has worked in the BSI Medical Devices Notified Body for 15 years.
Gary Robinson is the Commercial Director for Canada at BSI, a founder
of Entropy International (now part of BSI) and a co-author of the Butterworth and
Heinemann publication “The ISO 14001 EMS Implementation Handbook.”